Brain Tumor Trials

The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the
maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation
regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the
methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be
explored and tumor responses to treatment will be evaluated.

Solid Tumor Trials

This is an open label, multi-center, Phase 1/2 clinical trial in subjects with recurrent
adenocarcinoma of the ovary who have been previously treated with a minimum of two courses of
platinum-based chemotherapy, and up to two additional cytotoxic regimens that may also have
included platinum (no more than four total lines of prior therapy), with or without
bevacizumab, whose cancer has recurred within six months of the most recent platinum-based
chemotherapy. All eligible subjects will receive VAL 083 i.v. in a once weekly cycle until
disease progression, development of other unacceptable toxicity, death, withdrawal of
consent, loss to follow-up, or Sponsor ending the study, whichever occurs first.

Brain Tumor Trials

The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and
the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma.
Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be
evaluated.

Do You Have Questions?

The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.